Levofloxacin Sequential Therapy vs Levofloxacin Triple Therapy in the Second-Line Treatment of Helicobacter pylori: A Randomized Trial

• Published in: The American journal of gastroenterology Vol. 111; no. 3; pp. 381 - 387
• Main Authors: Liou, Jyh-Ming, Bair, Ming-Jong, Chen, Chieh-Chang, Lee, Yi-Chia, Chen, Mei-Jyh, Chen, Chien-Chuan, Tseng, Cheng-Hao, Fang, Yu-Jen, Lee, Ji-Yuh, Yang, Tsung-Hua, Luo, Jiing-Chyuan, Wu, Jeng-Yih, Chang, Wen-Hsiung, Chang, Chun-Chao, Chen, Chi-Yi, Chen, Po-Yueh, Shun, Chia-Tung, Hsu, Wen-Feng, Hung, Hsu-Wei, Lin, Jaw-Town, Chang, Chi-Yang, Wu, Ming-Shiang
• Format: Journal Article
• Language: English
• Published: United States Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins 01.03.2016
• Subjects: Adult; Aged; Amoxicillin - administration & dosage; Amoxicillin - adverse effects; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Drug Administration Schedule; Drug Monitoring - methods; Drug Therapy, Combination - methods; Female; Gastroenterology; Helicobacter Infections - diagnosis; Helicobacter Infections - drug therapy; Helicobacter pylori; Helicobacter pylori - drug effects; Helicobacter pylori - isolation & purification; Humans; Lansoprazole - administration & dosage; Lansoprazole - adverse effects; Levofloxacin - administration & dosage; Levofloxacin - adverse effects; Male; Metronidazole - administration & dosage; Metronidazole - adverse effects; Middle Aged; Stomach Diseases - drug therapy; Stomach Diseases - microbiology; Treatment Outcome
• ISSN: 0002-9270; 1572-0241; 1572-0241
• DOI: 10.1038/ajg.2015.439

The efficacy of levofloxacin triple therapy has fallen below 80% in the second-line treatment of Helicobacter pylori (H. pylori). We aimed to assess whether the levofloxacin sequential therapy is more effective than levofloxacin triple therapy in the second-line treatment. This open-label, randomized, multicenter trial was conducted between 2012 and 2015. H. pylori-infected subjects who failed from clarithromycin-based regimens (N=600) were randomized (1:1) to receive levofloxacin sequential therapy (LS: lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, levofloxacin, and metronidazole for another 5 days) or levofloxacin triple therapy (LT: lansoprazole, amoxicillin, and levofloxacin for 10 days). Successful eradication was defined as negative (13)C-urea breath test at least 6 weeks after treatment. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Antibiotic resistance was determined by agar dilution test. The prevalence of clarithromycin, levofloxacin, and metronidazole resistance was 60, 17.6, and 36.9%, respectively. The eradication rates of LS and LT were 84.3% (253/300) and 75.3% (226/300), respectively, in the ITT analysis (P=0.006) and 86.3% (253/293) and 78.8% (223/283), respectively, in the PP analysis (P=0.021). The efficacies of both LS and LT were affected by levofloxacin resistance. The secondary resistance of levofloxacin was 66.7 and 73.9% after LS and LT, respectively. The efficacies of LS and LT were not affected by the CYP2C19 polymorphism. Levofloxacin sequential therapy was more effective than levofloxacin triple therapy, and it is recommended in the second-line treatment for H. pylori ( NCT01537055).